Contaminated Medicines

Syllabus: General Studies Paper 1

Following the death of 66 children in Gambia, the World Health Organization (WHO) has raised an alert over four fever, cold and cough syrups made by an Indian company, urging people to not use them. All the four syrups 

• Promethazine Oral Solution, 
• Kofexmalin Baby Cough Syrup, 
• Makoff Baby Cough Syrup and 
• Magrip N Cold Syrup 

All are made by Haryana-based Maiden Pharmaceuticals.

• Laboratory analysis of samples of each of the four products confirms that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants. 
• India’s apex drug regulatory authority – the Central Drugs Standard Control Organisation (CDSCO) – has already launched an investigation into the matter.
• Diethylene glycol and ethylene glycol can cause toxic effects, including abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury that may lead to death.
• These medicinal products are substandard and unsafe for use, especially in children, and may result in serious injury or death, as per WHO.

Measures to be taken

• Individuals are advised to seek immediate medical advice from a qualified healthcare professional and report the incident to the National Regulatory Authority or National Pharmacovigilance Centre.
• Countries should increase surveillance of the supply chains to detect and remove the substandard products including surveillance of informal or unregulated markets.

About CDSCO

• The Central Drugs Standard Control Organization (CDSCO) is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act. CDSCO has six zonal offices, four sub-zonal offices, 13 port offices and seven laboratories under its control.

Major functions of CDSCO

• Regulatory control over the import of drugs
• approval of new drugs and clinical trials
• meetings of Drugs Consultative Committee (DCC) and Drugs Technical Advisory Board (DTAB)
• approval of certain licenses as Central License Approving Authority is exercised by the CDSCO headquarters.